AzTrials
AzTrials

Colorectal CancerPhase 2NCT00642603

A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

A Phase 2 study testing capecitabine [Xeloda], bevacizumab [Avastin] and oxaliplatin in people with Colorectal Cancer, run by Hoffmann-La Roche at 76 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
capecitabine [Xeloda], bevacizumab [Avastin] and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
76 sitesUnited States
Study dates
May 2008to Mar 2009
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, ≥18 years of age
  • Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
  • ≥1 measurable target lesion
  • Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Who cannot join

  • Prior systemic therapy for advanced or metastatic disease
  • History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
  • Clinically significant cardiovascular disease
  • Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
  • Chronic daily treatment with >325 mg/day aspirin

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Albuquerque, New Mexico, 87131-5636

  • Study site

    Alexandria, Louisiana, 71301

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Anaheim, California, 92801

  • Study site

    Arlington, Texas, 76014

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Beaumont, Texas, 77702-1449

  • Study site

    Bedford, Texas, 76022

  • Study site

    Brooklyn, New York, 11219

  • Study site

    Canton, Ohio, 44718

  • Study site

    Carrollton, Texas, 75010

  • Study site

    Charleston, South Carolina, 29403-5740

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Christiansburg, Virginia, 24073

  • Study site

    Colton, California, 92324

  • Study site

    Cookeville, Tennessee, 38501

  • Study site

    Corpus Christi, Texas, 78412

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75237

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Ephrata, Pennsylvania, 17522

  • Study site

    Eugene, Oregon, 97401-8122

  • Study site

    Florence, South Carolina, 29506

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Garland, Texas, 75042

  • Study site

    Great Falls, Montana, 59405

  • Study site

    Greenbrae, California, 94904

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Huntington Station, New York, 11746

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Lake Worth, Florida, 33431

  • Study site

    Langhorne, Pennsylvania, 19047

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Lewisville, Texas, 75067

  • Study site

    Loma Linda, California, 92354

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Mesquite, Texas, 75150

  • Study site

    Miami Shores, Florida, 33179

  • Study site

    Modesto, California, 95355

  • Study site

    Montebello, California, 90640

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Neptune City, New Jersey, 07754

  • Study site

    New Port Richey, Florida, 34655

  • Study site

    Niles, Illinois, 60714

  • Study site

    Norwich, Connecticut, 06360

  • Study site

    Ocala, Florida, 34474

  • Study site

    Ocoee, Florida, 34761

  • Study site

    Paducah, Kentucky, 42002

  • Study site

    Paris, Texas, 75460

  • Study site

    PARK Springs, Arizona, 71913

  • Study site

    Philadelphia, Pennsylvania, 19102

  • Study site

    Pittsfield, Massachusetts, 01201

  • Study site

    Pomona, California, 91767

  • Study site

    Round Rock, Texas, 78681

  • Study site

    Sacramento, California, 95816

  • Study site

    Salt Lake City, Utah, 84106

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    Scranton, Pennsylvania, 18510

  • Study site

    Seattle, Washington, 98133

  • Study site

    Sedona, Arizona, 86336

  • Study site

    Southlake, Texas, 76092

  • Study site

    Sugarland, Texas, 77479

  • Study site

    Sumter, South Carolina, 29150

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Waco, Texas, 76712

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    Webster, Texas, 77598-4420

  • Study site

    Westminster, Maryland, 21157

  • Study site

    Worcester, Massachusetts, 01608

Other trials in United States

About this study

Official title: A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer

This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Being tested
capecitabine [Xeloda], bevacizumab [Avastin], oxaliplatin, irinotecan
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabine [Xeloda]Drug

    1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

  • capecitabine [Xeloda]Drug

    1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

  • bevacizumab [Avastin]Drug

    5 mg/kg taken intravenously on Day 1 of each 2 week cycle

  • oxaliplatinDrug

    85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

  • irinotecanDrug

    135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Study groups in NCT00642603
Study groupRoleWhat they receive
XELOX + bevacizumab (Q2W)ExperimentalNot described
Receives: Drug: capecitabine [Xeloda]; Drug: bevacizumab [Avastin]; Drug: oxaliplatin
XELIRI + bevacizumab (Q2W)ExperimentalNot described
Receives: Drug: capecitabine [Xeloda]; Drug: bevacizumab [Avastin]; Drug: irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) in U.S. Patients Only

    PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.

    Measured: From first patient enrolled up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00642603
Sponsor's protocol ID
ML21567
Status last verified
Feb 2018
First submitted
19 Mar 2008
Last updated
26 Aug 2026

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in